Role of co-trimoxazole prophylaxis in reducing mortality in HIV infected adults being treated for tuberculosis: randomised clinical trial
Identifieur interne : 000E55 ( Istex/Corpus ); précédent : 000E54; suivant : 000E56Role of co-trimoxazole prophylaxis in reducing mortality in HIV infected adults being treated for tuberculosis: randomised clinical trial
Auteurs : Andrew J. Nunn ; Peter Mwaba ; Chifumbe Chintu ; Alwyn Mwinga ; Janet H. Darbyshire ; Alimuddin ZumlaSource :
- BMJ [ 0959-8138 ] ; 2008-07-10.
English descriptors
- KwdEn :
- Active tuberculosis, Additional visits, Adherence levels, Adverse events, Antiretroviral, Antiretroviral treatment, Antituberculosis, Antituberculosis chemotherapy, Antituberculosis treatment, Bacterial infections, Bacterial resistance, Baseline characteristics, Body mass index, Cause mortality, Clinic, Clinical trials, Clinical trials unit, Confidence interval, Cotrimoxazole, Cotrimoxazole prophylaxis, Death rate, Death rates, Eligible participants, Expert consultation, Exploratory analyses, Hazard ratio, Historical cohort, Karonga district, National programmes, Nations programme, Online, Opportunistic infections, Optimal timing, Participant, Person years, Placebo, Placebo group, Placebo participants, Positive adults, Positive patients, Positive people, Prophylaxis, Pulmonary tuberculosis, Randomisation, Randomised, Randomised group, Randomised placebo, Randomised trial, Retreatment, Retreatment regimen, Study drug, Study number, Study population, Survival analysis, Trial drug, Trial tablets, Tuberc lung, Tuberculosis, Tuberculosis patients, Tuberculosis treatment, University college london, University teaching hospital, Untreated, Untreated participants, Untreated patients, Voluntary counselling, World health organization, Zambia, Zambian ministry.
- Teeft :
- Active tuberculosis, Additional visits, Adherence levels, Adverse events, Antiretroviral, Antiretroviral treatment, Antituberculosis, Antituberculosis chemotherapy, Antituberculosis treatment, Bacterial infections, Bacterial resistance, Baseline characteristics, Body mass index, Cause mortality, Clinic, Clinical trials, Clinical trials unit, Confidence interval, Cotrimoxazole, Cotrimoxazole prophylaxis, Death rate, Death rates, Eligible participants, Expert consultation, Exploratory analyses, Hazard ratio, Historical cohort, Karonga district, National programmes, Nations programme, Online, Opportunistic infections, Optimal timing, Participant, Person years, Placebo, Placebo group, Placebo participants, Positive adults, Positive patients, Positive people, Prophylaxis, Pulmonary tuberculosis, Randomisation, Randomised, Randomised group, Randomised placebo, Randomised trial, Retreatment, Retreatment regimen, Study drug, Study number, Study population, Survival analysis, Trial drug, Trial tablets, Tuberc lung, Tuberculosis, Tuberculosis patients, Tuberculosis treatment, University college london, University teaching hospital, Untreated, Untreated participants, Untreated patients, Voluntary counselling, World health organization, Zambia, Zambian ministry.
Abstract
Objective To assess the impact of prophylactic oral co-trimoxazole in reducing mortality in HIV positive Zambian adults being treated for pulmonary tuberculosis. Design Double blind placebo controlled randomised clinical trial. Participants Two groups of antiretroviral treatment naive adults with HIV infection: patients newly diagnosed as having tuberculosis and receiving tuberculosis treatment either for the first time or for retreatment after relapse; previously treated patients not receiving treatment. Intervention Oral co-trimoxazole or matching placebo daily. Primary outcome measures Time to death and occurrence of serious adverse events related to study drug. Results 1003 patients were randomised: 835 (416 co-trimoxazole, 419 placebo) were receiving treatment for tuberculosis, 762 (376 co-trimoxazole, 386 placebo) of them newly diagnosed previously untreated patients and 73 (40 co-trimoxazole, 33 placebo) receiving a retreatment regimen; 168 (84 co-trimoxazole, 84 placebo) were not on treatment but had received treatment in the past. Of 835 participants receiving tuberculosis treatment, follow-up information was available for 757, with a total of 1012.6 person years of follow-up. A total of 310 (147 co-trimoxazole, 163 placebo) participants died, corresponding to death rates of 27.3 and 34.4 per 100 person years. In the Cox regression analysis, the hazard ratio for death (co-trimoxazole:placebo) was 0.79 (95% confidence interval 0.63 to 0.99). The effect of co-trimoxazole waned with time, possibly owing to falling adherence levels; in a per protocol analysis based on patients who spent at least 90% of their time at risk supplied with study drug, the hazard ratio was 0.65 (0.45 to 0.93). Conclusions Prophylaxis with co-trimoxazole reduces mortality in HIV infected adults with pulmonary tuberculosis. Co-trimoxazole was generally safe and well tolerated. Trial registration Current Controlled Trials ISRCTN15281875.
Url:
DOI: 10.1136/bmj.a257
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ISTEX:2DC018BB100350F819B73F0A90E765628B60E48CLe document en format XML
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xml:lang="en"><term>Active tuberculosis</term><term>Additional visits</term><term>Adherence levels</term><term>Adverse events</term><term>Antiretroviral</term><term>Antiretroviral treatment</term><term>Antituberculosis</term><term>Antituberculosis chemotherapy</term><term>Antituberculosis treatment</term><term>Bacterial infections</term><term>Bacterial resistance</term><term>Baseline characteristics</term><term>Body mass index</term><term>Cause mortality</term><term>Clinic</term><term>Clinical trials</term><term>Clinical trials unit</term><term>Confidence interval</term><term>Cotrimoxazole</term><term>Cotrimoxazole prophylaxis</term><term>Death rate</term><term>Death rates</term><term>Eligible participants</term><term>Expert consultation</term><term>Exploratory analyses</term><term>Hazard ratio</term><term>Historical cohort</term><term>Karonga district</term><term>National programmes</term><term>Nations programme</term><term>Online</term><term>Opportunistic infections</term><term>Optimal timing</term><term>Participant</term><term>Person years</term><term>Placebo</term><term>Placebo group</term><term>Placebo participants</term><term>Positive adults</term><term>Positive patients</term><term>Positive people</term><term>Prophylaxis</term><term>Pulmonary tuberculosis</term><term>Randomisation</term><term>Randomised</term><term>Randomised group</term><term>Randomised placebo</term><term>Randomised trial</term><term>Retreatment</term><term>Retreatment regimen</term><term>Study drug</term><term>Study number</term><term>Study population</term><term>Survival analysis</term><term>Trial drug</term><term>Trial tablets</term><term>Tuberc lung</term><term>Tuberculosis</term><term>Tuberculosis patients</term><term>Tuberculosis treatment</term><term>University college london</term><term>University teaching hospital</term><term>Untreated</term><term>Untreated participants</term><term>Untreated patients</term><term>Voluntary counselling</term><term>World health organization</term><term>Zambia</term><term>Zambian ministry</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Active tuberculosis</term><term>Additional visits</term><term>Adherence levels</term><term>Adverse events</term><term>Antiretroviral</term><term>Antiretroviral treatment</term><term>Antituberculosis</term><term>Antituberculosis chemotherapy</term><term>Antituberculosis treatment</term><term>Bacterial infections</term><term>Bacterial resistance</term><term>Baseline characteristics</term><term>Body mass index</term><term>Cause mortality</term><term>Clinic</term><term>Clinical trials</term><term>Clinical trials unit</term><term>Confidence interval</term><term>Cotrimoxazole</term><term>Cotrimoxazole prophylaxis</term><term>Death rate</term><term>Death rates</term><term>Eligible participants</term><term>Expert consultation</term><term>Exploratory analyses</term><term>Hazard ratio</term><term>Historical cohort</term><term>Karonga district</term><term>National programmes</term><term>Nations programme</term><term>Online</term><term>Opportunistic infections</term><term>Optimal timing</term><term>Participant</term><term>Person years</term><term>Placebo</term><term>Placebo group</term><term>Placebo participants</term><term>Positive adults</term><term>Positive patients</term><term>Positive people</term><term>Prophylaxis</term><term>Pulmonary tuberculosis</term><term>Randomisation</term><term>Randomised</term><term>Randomised group</term><term>Randomised placebo</term><term>Randomised trial</term><term>Retreatment</term><term>Retreatment regimen</term><term>Study drug</term><term>Study number</term><term>Study population</term><term>Survival analysis</term><term>Trial drug</term><term>Trial tablets</term><term>Tuberc lung</term><term>Tuberculosis</term><term>Tuberculosis patients</term><term>Tuberculosis treatment</term><term>University college london</term><term>University teaching hospital</term><term>Untreated</term><term>Untreated participants</term><term>Untreated patients</term><term>Voluntary counselling</term><term>World health organization</term><term>Zambia</term><term>Zambian ministry</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objective To assess the impact of prophylactic oral co-trimoxazole in reducing mortality in HIV positive Zambian adults being treated for pulmonary tuberculosis. Design Double blind placebo controlled randomised clinical trial. Participants Two groups of antiretroviral treatment naive adults with HIV infection: patients newly diagnosed as having tuberculosis and receiving tuberculosis treatment either for the first time or for retreatment after relapse; previously treated patients not receiving treatment. Intervention Oral co-trimoxazole or matching placebo daily. Primary outcome measures Time to death and occurrence of serious adverse events related to study drug. Results 1003 patients were randomised: 835 (416 co-trimoxazole, 419 placebo) were receiving treatment for tuberculosis, 762 (376 co-trimoxazole, 386 placebo) of them newly diagnosed previously untreated patients and 73 (40 co-trimoxazole, 33 placebo) receiving a retreatment regimen; 168 (84 co-trimoxazole, 84 placebo) were not on treatment but had received treatment in the past. Of 835 participants receiving tuberculosis treatment, follow-up information was available for 757, with a total of 1012.6 person years of follow-up. A total of 310 (147 co-trimoxazole, 163 placebo) participants died, corresponding to death rates of 27.3 and 34.4 per 100 person years. In the Cox regression analysis, the hazard ratio for death (co-trimoxazole:placebo) was 0.79 (95% confidence interval 0.63 to 0.99). The effect of co-trimoxazole waned with time, possibly owing to falling adherence levels; in a per protocol analysis based on patients who spent at least 90% of their time at risk supplied with study drug, the hazard ratio was 0.65 (0.45 to 0.93). Conclusions Prophylaxis with co-trimoxazole reduces mortality in HIV infected adults with pulmonary tuberculosis. Co-trimoxazole was generally safe and well tolerated. 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timing</json:string><json:string>tuberc lung</json:string><json:string>study population</json:string><json:string>expert consultation</json:string><json:string>clinic</json:string></teeft></keywords><author><json:item><name>Andrew J Nunn</name><affiliations><json:string>Medical Research Council Clinical Trials Unit, London NW1 2DA</json:string><json:string>Correspondence to: A Nunn ajn@ctu.mrc.ac.uk</json:string></affiliations></json:item><json:item><name>Peter Mwaba</name><affiliations><json:string>University Teaching Hospital, UNZA School of Medicine, Box 50110, Lusaka, Zambia</json:string></affiliations></json:item><json:item><name>Chifumbe Chintu</name><affiliations><json:string>University Teaching Hospital, UNZA School of Medicine, Box 50110, Lusaka, Zambia</json:string></affiliations></json:item><json:item><name>Alwyn Mwinga</name><affiliations><json:string>University Teaching Hospital, UNZA School of Medicine, Box 50110, Lusaka, Zambia</json:string></affiliations></json:item><json:item><name>Janet H Darbyshire</name><affiliations><json:string>Medical Research Council Clinical Trials Unit, London NW1 2DA</json:string></affiliations></json:item><json:item><name>Alimuddin Zumla</name><affiliations><json:string>University College London, Centre for Infectious Diseases and International Health, London W1T 4JF</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Infectious diseases</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Epidemiologic studies</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Immunology (including allergy)</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Tuberculosis</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Sexual health</value></json:item></subject><articleId><json:string>nuna543728</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>Objective To assess the impact of prophylactic oral co-trimoxazole in reducing mortality in HIV positive Zambian adults being treated for pulmonary tuberculosis. Design Double blind placebo controlled randomised clinical trial. Participants Two groups of antiretroviral treatment naive adults with HIV infection: patients newly diagnosed as having tuberculosis and receiving tuberculosis treatment either for the first time or for retreatment after relapse; previously treated patients not receiving treatment. Intervention Oral co-trimoxazole or matching placebo daily. Primary outcome measures Time to death and occurrence of serious adverse events related to study drug. Results 1003 patients were randomised: 835 (416 co-trimoxazole, 419 placebo) were receiving treatment for tuberculosis, 762 (376 co-trimoxazole, 386 placebo) of them newly diagnosed previously untreated patients and 73 (40 co-trimoxazole, 33 placebo) receiving a retreatment regimen; 168 (84 co-trimoxazole, 84 placebo) were not on treatment but had received treatment in the past. Of 835 participants receiving tuberculosis treatment, follow-up information was available for 757, with a total of 1012.6 person years of follow-up. A total of 310 (147 co-trimoxazole, 163 placebo) participants died, corresponding to death rates of 27.3 and 34.4 per 100 person years. In the Cox regression analysis, the hazard ratio for death (co-trimoxazole:placebo) was 0.79 (95% confidence interval 0.63 to 0.99). The effect of co-trimoxazole waned with time, possibly owing to falling adherence levels; in a per protocol analysis based on patients who spent at least 90% of their time at risk supplied with study drug, the hazard ratio was 0.65 (0.45 to 0.93). Conclusions Prophylaxis with co-trimoxazole reduces mortality in HIV infected adults with pulmonary tuberculosis. Co-trimoxazole was generally safe and well tolerated. Trial registration Current Controlled Trials ISRCTN15281875.</abstract><qualityIndicators><score>7.666</score><pdfVersion>1.2</pdfVersion><pdfPageSize>595 x 794 pts</pdfPageSize><refBibsNative>false</refBibsNative><keywordCount>5</keywordCount><abstractCharCount>1950</abstractCharCount><pdfWordCount>4666</pdfWordCount><pdfCharCount>31646</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>274</abstractWordCount></qualityIndicators><title>Role of co-trimoxazole prophylaxis in reducing mortality in HIV infected adults being treated for tuberculosis: randomised clinical trial</title><pmid><json:string>18617486</json:string></pmid><corporate><json:item><name>for the UNZA-UCLMS Project LUCOT 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ajn@ctu.mrc.ac.uk</affiliation></author><author xml:id="author-0000"><persName><forename type="first">Andrew J</forename><surname>Nunn</surname></persName><affiliation>Medical Research Council Clinical Trials Unit, London NW1 2DA</affiliation><affiliation>Correspondence to: A Nunn ajn@ctu.mrc.ac.uk</affiliation></author><author xml:id="author-0001"><persName><forename type="first">Peter</forename><surname>Mwaba</surname></persName><affiliation>University Teaching Hospital, UNZA School of Medicine, Box 50110, Lusaka, Zambia</affiliation></author><author xml:id="author-0002"><persName><forename type="first">Chifumbe</forename><surname>Chintu</surname></persName><affiliation>University Teaching Hospital, UNZA School of Medicine, Box 50110, Lusaka, Zambia</affiliation></author><author xml:id="author-0003"><persName><forename type="first">Alwyn</forename><surname>Mwinga</surname></persName><affiliation>University Teaching Hospital, UNZA School of Medicine, Box 50110, Lusaka, Zambia</affiliation></author><author xml:id="author-0004"><persName><forename type="first">Janet H</forename><surname>Darbyshire</surname></persName><affiliation>Medical Research Council Clinical Trials Unit, London NW1 2DA</affiliation></author><author xml:id="author-0005"><persName><forename type="first">Alimuddin</forename><surname>Zumla</surname></persName><affiliation>University College London, Centre for Infectious Diseases and International Health, London W1T 4JF</affiliation></author><idno type="istex">2DC018BB100350F819B73F0A90E765628B60E48C</idno><idno type="ark">ark:/67375/NVC-GKRZ791Z-T</idno><idno type="DOI">10.1136/bmj.a257</idno><idno type="href">bmj-337-bmj-a257.pdf</idno><idno type="article-id">nuna543728</idno><idno type="PMID">18617486</idno><idno type="local">bmj;337/jul10_1/a257</idno></analytic><monogr><title level="j">BMJ</title><title level="j" type="abbrev">BMJ</title><idno type="pISSN">0959-8138</idno><idno type="eISSN">1468-5833</idno><idno type="publisher-id">bmj</idno><idno type="PublisherID-hwp">bmj</idno><idno type="PublisherID-nlm-ta">BMJ</idno><imprint><publisher>British Medical Journal Publishing Group</publisher><date type="published" when="2008-07-10"></date><biblScope unit="volume">337</biblScope></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2008-07-10</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Objective To assess the impact of prophylactic oral co-trimoxazole in reducing mortality in HIV positive Zambian adults being treated for pulmonary tuberculosis. Design Double blind placebo controlled randomised clinical trial. Participants Two groups of antiretroviral treatment naive adults with HIV infection: patients newly diagnosed as having tuberculosis and receiving tuberculosis treatment either for the first time or for retreatment after relapse; previously treated patients not receiving treatment. Intervention Oral co-trimoxazole or matching placebo daily. Primary outcome measures Time to death and occurrence of serious adverse events related to study drug. Results 1003 patients were randomised: 835 (416 co-trimoxazole, 419 placebo) were receiving treatment for tuberculosis, 762 (376 co-trimoxazole, 386 placebo) of them newly diagnosed previously untreated patients and 73 (40 co-trimoxazole, 33 placebo) receiving a retreatment regimen; 168 (84 co-trimoxazole, 84 placebo) were not on treatment but had received treatment in the past. Of 835 participants receiving tuberculosis treatment, follow-up information was available for 757, with a total of 1012.6 person years of follow-up. A total of 310 (147 co-trimoxazole, 163 placebo) participants died, corresponding to death rates of 27.3 and 34.4 per 100 person years. In the Cox regression analysis, the hazard ratio for death (co-trimoxazole:placebo) was 0.79 (95% confidence interval 0.63 to 0.99). The effect of co-trimoxazole waned with time, possibly owing to falling adherence levels; in a per protocol analysis based on patients who spent at least 90% of their time at risk supplied with study drug, the hazard ratio was 0.65 (0.45 to 0.93). Conclusions Prophylaxis with co-trimoxazole reduces mortality in HIV infected adults with pulmonary tuberculosis. Co-trimoxazole was generally safe and well tolerated. Trial registration Current Controlled Trials ISRCTN15281875.</p></abstract><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Infectious diseases</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Epidemiologic studies</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Immunology (including allergy)</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Tuberculosis</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Sexual health</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2008-07-10">Created</change><change when="2008-07-10">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/2DC018BB100350F819B73F0A90E765628B60E48C/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="hwp">bmj</journal-id><journal-id journal-id-type="nlm-ta">BMJ</journal-id><journal-id journal-id-type="publisher-id">bmj</journal-id><journal-title>BMJ</journal-title><abbrev-journal-title abbrev-type="publisher">BMJ</abbrev-journal-title><issn pub-type="ppub">0959-8138</issn><issn pub-type="epub">1468-5833</issn><publisher><publisher-name>British Medical Journal Publishing Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">nuna543728</article-id><article-id pub-id-type="doi">10.1136/bmj.a257</article-id><article-id pub-id-type="other">bmj;337/jul10_1/a257</article-id><article-id pub-id-type="other">jul10_1</article-id><article-id pub-id-type="pmid">18617486</article-id><article-id pub-id-type="other">bmj.a257</article-id><article-id pub-id-type="other">bmj.a257</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Infectious diseases</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Epidemiologic studies</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Immunology (including allergy)</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Tuberculosis</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Sexual health</subject></subj-group></article-categories><title-group><article-title>Role of co-trimoxazole prophylaxis in reducing mortality in HIV infected adults being treated for tuberculosis: randomised clinical trial</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Nunn</surname><given-names>Andrew J</given-names></name><role>associate director </role><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Mwaba</surname><given-names>Peter</given-names></name><role>director and consultant physician</role><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Chintu</surname><given-names>Chifumbe</given-names></name><role>professor of paediatrics </role><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Mwinga</surname><given-names>Alwyn</given-names></name><role>senior scientist</role><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Darbyshire</surname><given-names>Janet H</given-names></name><role>director</role><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Zumla</surname><given-names>Alimuddin</given-names></name><role>professor and director</role><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib><collab>for the UNZA-UCLMS Project LUCOT Collaboration</collab></contrib><aff id="aff1"><label>1</label>Medical Research Council Clinical Trials Unit, London NW1 2DA</aff><aff id="aff2"><label>2</label>University Teaching Hospital, UNZA School of Medicine, Box 50110, Lusaka, Zambia</aff><aff id="aff3"><label>3</label>University College London, Centre for Infectious Diseases and International Health, London W1T 4JF</aff></contrib-group><author-notes><corresp>Correspondence to: A Nunn <email>ajn@ctu.mrc.ac.uk</email></corresp></author-notes><pub-date pub-type="epub-original"><year>2008</year></pub-date><pub-date pub-type="epub"><day>10</day><month>7</month><year>2008</year></pub-date><volume>337</volume><volume-id pub-id-type="other">337</volume-id><volume-id pub-id-type="other">337</volume-id><elocation-id>a257</elocation-id><history><date date-type="accepted"><day>9</day><month>May</month><year>2008</year></date></history><permissions><copyright-statement>© BMJ Publishing Group Ltd 2008</copyright-statement><copyright-year>2008</copyright-year><copyright-holder>BMJ Publishing Group Ltd</copyright-holder></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="bmj-337-bmj-a257.pdf"></self-uri><abstract><p><bold>Objective</bold> To assess the impact of prophylactic oral co-trimoxazole in reducing mortality in HIV positive Zambian adults being treated for pulmonary tuberculosis.</p><p><bold>Design</bold> Double blind placebo controlled randomised clinical trial.</p><p><bold>Participants</bold> Two groups of antiretroviral treatment naive adults with HIV infection: patients newly diagnosed as having tuberculosis and receiving tuberculosis treatment either for the first time or for retreatment after relapse; previously treated patients not receiving treatment.</p><p><bold>Intervention</bold> Oral co-trimoxazole or matching placebo daily.</p><p><bold>Primary outcome measures</bold> Time to death and occurrence of serious adverse events related to study drug.</p><p><bold>Results</bold> 1003 patients were randomised: 835 (416 co-trimoxazole, 419 placebo) were receiving treatment for tuberculosis, 762 (376 co-trimoxazole, 386 placebo) of them newly diagnosed previously untreated patients and 73 (40 co-trimoxazole, 33 placebo) receiving a retreatment regimen; 168 (84 co-trimoxazole, 84 placebo) were not on treatment but had received treatment in the past. Of 835 participants receiving tuberculosis treatment, follow-up information was available for 757, with a total of 1012.6 person years of follow-up. A total of 310 (147 co-trimoxazole, 163 placebo) participants died, corresponding to death rates of 27.3 and 34.4 per 100 person years. In the Cox regression analysis, the hazard ratio for death (co-trimoxazole:placebo) was 0.79 (95% confidence interval 0.63 to 0.99). The effect of co-trimoxazole waned with time, possibly owing to falling adherence levels; in a per protocol analysis based on patients who spent at least 90% of their time at risk supplied with study drug, the hazard ratio was 0.65 (0.45 to 0.93).</p><p><bold>Conclusions</bold> Prophylaxis with co-trimoxazole reduces mortality in HIV infected adults with pulmonary tuberculosis. Co-trimoxazole was generally safe and well tolerated.</p><p><bold>Trial registration</bold> Current Controlled Trials <ext-link ext-link-type="isrctn" xlink:href="ISRCTN15281875">ISRCTN15281875</ext-link>.</p></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>Role of co-trimoxazole prophylaxis in reducing mortality in HIV infected adults being treated for tuberculosis: randomised clinical trial</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>Role of co-trimoxazole prophylaxis in reducing mortality in HIV infected adults being treated for tuberculosis: randomised clinical trial</title></titleInfo><name type="corporate"><namePart>for the UNZA-UCLMS Project LUCOT Collaboration</namePart><affiliation>Correspondence to: A Nunn ajn@ctu.mrc.ac.uk</affiliation></name><name type="personal"><namePart type="given">Andrew J</namePart><namePart type="family">Nunn</namePart><affiliation>Medical Research Council Clinical Trials Unit, London NW1 2DA</affiliation><affiliation>Correspondence to: A Nunn ajn@ctu.mrc.ac.uk</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Peter</namePart><namePart type="family">Mwaba</namePart><affiliation>University Teaching Hospital, UNZA School of Medicine, Box 50110, Lusaka, Zambia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Chifumbe</namePart><namePart type="family">Chintu</namePart><affiliation>University Teaching Hospital, UNZA School of Medicine, Box 50110, Lusaka, Zambia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Alwyn</namePart><namePart type="family">Mwinga</namePart><affiliation>University Teaching Hospital, UNZA School of Medicine, Box 50110, Lusaka, Zambia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Janet H</namePart><namePart type="family">Darbyshire</namePart><affiliation>Medical Research Council Clinical Trials Unit, London NW1 2DA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Alimuddin</namePart><namePart type="family">Zumla</namePart><affiliation>University College London, Centre for Infectious Diseases and International Health, London W1T 4JF</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</genre><originInfo><publisher>British Medical Journal Publishing Group</publisher><dateIssued encoding="w3cdtf">2008-07-10</dateIssued><dateCreated encoding="w3cdtf">2008-07-10</dateCreated><copyrightDate encoding="w3cdtf">2008</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><abstract>Objective To assess the impact of prophylactic oral co-trimoxazole in reducing mortality in HIV positive Zambian adults being treated for pulmonary tuberculosis. Design Double blind placebo controlled randomised clinical trial. Participants Two groups of antiretroviral treatment naive adults with HIV infection: patients newly diagnosed as having tuberculosis and receiving tuberculosis treatment either for the first time or for retreatment after relapse; previously treated patients not receiving treatment. Intervention Oral co-trimoxazole or matching placebo daily. Primary outcome measures Time to death and occurrence of serious adverse events related to study drug. Results 1003 patients were randomised: 835 (416 co-trimoxazole, 419 placebo) were receiving treatment for tuberculosis, 762 (376 co-trimoxazole, 386 placebo) of them newly diagnosed previously untreated patients and 73 (40 co-trimoxazole, 33 placebo) receiving a retreatment regimen; 168 (84 co-trimoxazole, 84 placebo) were not on treatment but had received treatment in the past. Of 835 participants receiving tuberculosis treatment, follow-up information was available for 757, with a total of 1012.6 person years of follow-up. A total of 310 (147 co-trimoxazole, 163 placebo) participants died, corresponding to death rates of 27.3 and 34.4 per 100 person years. In the Cox regression analysis, the hazard ratio for death (co-trimoxazole:placebo) was 0.79 (95% confidence interval 0.63 to 0.99). The effect of co-trimoxazole waned with time, possibly owing to falling adherence levels; in a per protocol analysis based on patients who spent at least 90% of their time at risk supplied with study drug, the hazard ratio was 0.65 (0.45 to 0.93). Conclusions Prophylaxis with co-trimoxazole reduces mortality in HIV infected adults with pulmonary tuberculosis. Co-trimoxazole was generally safe and well tolerated. Trial registration Current Controlled Trials ISRCTN15281875.</abstract><relatedItem type="host"><titleInfo><title>BMJ</title></titleInfo><titleInfo type="abbreviated"><title>BMJ</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><subject><genre>hwp-journal-coll</genre><topic>Infectious diseases</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Epidemiologic studies</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Immunology (including allergy)</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Tuberculosis</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Sexual health</topic></subject><identifier type="ISSN">0959-8138</identifier><identifier type="eISSN">1468-5833</identifier><identifier type="PublisherID">bmj</identifier><identifier type="PublisherID-hwp">bmj</identifier><identifier type="PublisherID-nlm-ta">BMJ</identifier><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>337</number></detail></part></relatedItem><identifier type="istex">2DC018BB100350F819B73F0A90E765628B60E48C</identifier><identifier type="ark">ark:/67375/NVC-GKRZ791Z-T</identifier><identifier type="DOI">10.1136/bmj.a257</identifier><identifier type="href">bmj-337-bmj-a257.pdf</identifier><identifier type="ArticleID">nuna543728</identifier><identifier type="PMID">18617486</identifier><identifier type="local">bmj;337/jul10_1/a257</identifier><accessCondition type="use and reproduction" contentType="copyright">© BMJ Publishing Group Ltd 2008</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-7M42M2QJ-2">bmj</recordContentSource><recordOrigin>© BMJ Publishing Group Ltd 2008</recordOrigin></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/document/2DC018BB100350F819B73F0A90E765628B60E48C/metadata/json</uri></json:item></metadata><annexes><json:item><extension>jpeg</extension><original>true</original><mimetype>image/jpeg</mimetype><uri>https://api.istex.fr/document/2DC018BB100350F819B73F0A90E765628B60E48C/annexes/jpeg</uri></json:item></annexes><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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